BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXCELSIUS GPS

    MDR report key: 18856758 · Received March 7, 2024

    Report

    Report Number
    3004142400-2021-00244
    Event Type
    Death
    Date Received
    March 7, 2024
    Date of Event
    October 5, 2021
    Report Date
    February 27, 2024
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    OLO
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT AN EXCELSIUS ROBOT WAS IN USE WHEN A PATIENT EXPERIENCED ADVERSE HEALTH EFFECTS AND PASSED AWAY. ADDITIONAL INFORMATION PROVIDED THAT NO DEVICE MALFUNCTION OR USER ERROR OCCURRED DURING THE PROCEDURE. DUE TO THE REPORTED EFFECTS TO THE PATIENT NOT BEING RELATED TO ANY GLOBUS MEDICAL PRODUCTS, THIS EVENT IS DETERMINED TO BE NOT REPORTEABLE. THE PURPOSE OF THIS REPORT IS IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN EXCELSIUS ROBOT WAS IN USE WHEN A PATIENT EXPERIENCED ADVERSE HEALTH EFFECTS AND PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2196299 EXCELSIUS GPS EXCELSIUS GPS - SPINE SOFTWARE MODEL OLO GLOBUS MEDICAL, INC. 999.893 GPS-0295

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Death